# K030411: Proximate PPH Hemorrhoidal Circular Stapler and Accessories, Model PPH03

- Pathway: 510(k) (Traditional)
- Applicant: Ethicon Endo-Surgery, Inc.
- Decided: Mar 20, 2003 after 41 days
- Product code: GDW (Staple, Implantable)
- Device class: 2
- Regulation: 21 CFR 878.4750
- Recalls of this device: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K940967 (1994). 3 ancestors in all.
6 later devices descend from it; 4 cite it directly.
4 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991030: Proximate HCS Hemorrhoidal Circular Stapler and Accessories, Ethicon Endo-Surgery, Inc. (1999)

## Most influential descendants
- K162707: Single Use Circular Stapler, Single Use Hemorrhoidal Circular Stapler, Single Patient Use Linear Stapler and Reload, Single Patient Use Linear Cutter and Reload, Single Patient Use Endo Cutter and Reload, Single Patient Use Transverse Cutter and Reload (2017), 1 descendant of its own
- K103470: Panther Group of Surgical Includes: Oanther Circular Stapler; Panther Hemorrhoidal Circular Stapler; Panther Linear Stap (2011), 1 descendant of its own
- K201639: Disposable Circular Staple, Disposable Hemorrhoidal Stapler, Disposable Linear Stapler and Reloads, Disposable Linear Cutter Stapler and Reloads, Disposable Endoscopic Linear Cutter Stapler and Reloads (2021), 0 descendants of its own
- K200320: Mirus Circular Stapler, Mirus Linear Cutter and Reload, Mirus Hemorrhoidal Circular Stapler, Mirus Linear Stapler and Reload (2021), 0 descendants of its own
- K183477: easyPPHTM Hemorrhoidal Stapler for Single Use (2019), 0 descendants of its own

## Recalls of this device
- Aug 3, 2012 · Class I · Z-0057-2013: Ethicon Endo-Surgery initiated this voluntary global recall for specific production lots of PROXIMATE PPH Hemorrhoidal Circular Stapler and Accessories 33mm (PPH01 and PPH03) and Transtar Circular Sta

## Indications for use
The PROXIMATE? PPH Hemorrhoidal Circular Stapler and accessories have application throughout the anal canal to perform surgical treatment of hemorrhoidal disease.

Source page: https://510kreport.com/device/K030411
Methodology: https://510kreport.com/methodology